Radioactive material is used in nuclear medicine for diagnostic and therapeutic purposes by injecting a patient with a small dose of the radioactive material, which concentrates in certain organs or regions of the patient. Radioactive materials typically used for nuclear medicine include Technetium-99m (“Tc-99m”), Indium-111m (“In-111”), Thallium-201, and Strontium-87m, among others.
Such radioactive materials may be produced using a radionuclide generator. Radionuclide generators generally include a column that has media for retaining a long-lived parent radionuclide that spontaneously decays into a daughter radionuclide that has a relatively short half-life. The column may be incorporated into a column assembly that has a needle-like outlet port that receives an evacuated vial to draw saline or other eluant liquid, provided to a needle-like inlet port, through a flow path of the column assembly, including the column itself. This liquid may elute and deliver daughter radionuclide from the column and to the evacuated vial for subsequent use in nuclear medical imaging applications, among other uses.
Prior to use in medical applications, radionuclide generators are sterilized such that when sterile eluant is eluted through the device, the resulting elution is also sterile and suitable for injection into a patient. Additionally, column assemblies of radionuclide generators intended for use in the medical industry generally undergo sterility testing to ensure the column assemblies are sterile and suitable for producing sterile, injectable elutions.
At least some known methods of sterility testing column assemblies require an extended period of time between collection and processing of a sterility test sample, and/or excessive handling of a vial in which an elution sample is collected for use in sterility testing. These circumstances may result in false negative results and false positive results. Accordingly, a need exists for improved systems and methods for sterility testing radionuclide generators.
This Background section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present disclosure, which are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.